Clinical trials: Antibiotics Resistance
Pneumonia
Ventilator-Associated Pneumonia/Hospital-Acquired Pneumonia Requiring Mechanical Ventilatory Support
The purpose of the study is to find out if high dose antibiotic (meropenem, MERREM® I.V.), along with another drug called an aminoglycoside (a different type of antibiotic) is effective in decreasing or reducing the rate of…
- Trial name
- NCT00050401
- Testing
- MERREM I.V. 2g as a 3 hour infusion every 8 hours, vancomycin I.V. 1 g every 12 hours, tobramycin I.V. 5 mg/kg every 24 hours
- Where
- 10 sites in United States
- Volunteers
- 500 people
- Sponsor
- Pfizer
Staphylococcus Aureus Bacteremia, Anti-Bacterial Agents
Phase IIa Clinical Study of N-Rephasin® SAL200
This study is performed to evaluate safety and to explore the efficacy of a single intravenous dose of N-Rephasin® SAL200 (3 mg/kg) in addition to the conventional standard treatment, for persistent Staphylococcus aureus…
- Trial name
- NCT03089697
- Testing
- N-Rephasin® SAL200
- Where
- 2 sites in South Korea
- Volunteers
- 25 people
- Sponsor
- Intron Biotechnology, Inc.
Prosthetic Joint Infection
Study to Evaluate Safety and Activity of TRL1068 in Prosthetic Joint Infections
TRL1068 is expected to eliminate the pathogen-protecting biofilm in the prosthetic joint and surrounding tissue, thus making these pathogens substantially more susceptible to established antibiotic treatment regimens.
- Trial name
- NCT04763759
- Testing
- TRL1068, a human monoclonal antibody
- Where
- 9 sites in United States
- Volunteers
- 15 people
- Sponsor
- Trellis Bioscience LLC
Mycobacterium Infections, Nontuberculous
Pilot Trial of Inhaled Molgramostim in Non-tuberculous Mycobacterial (NTM) Infection
The trial is an open-label, non-controlled, multicenter, pilot clinical trial of inhaled molgramostim (recombinant human granulocyte-macrophage colony stimulating factor; rhGM-CSF) in subjects with persistent pulmonary…
- Trial name
- OPTIMA (NCT03421743)
- Testing
- Inhaled molgramostim, Antimycobacterial regimen
- Where
- 5 sites in Australia, United Kingdom
- Volunteers
- 32 people
- Sponsor
- Savara Inc.
Lung Diseases, Pulmonary Disease
A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis
Although Cystic Fibrosis is a complex genetic disease affecting many organs, lung disease is the primary cause of mortality. The objective of this study is to determine the safety and tolerability of SNSP113 in healthy subjects…
- Conditions
- Lung Diseases, Pulmonary Disease, Cystic Fibrosis, Cystic Fibrosis Lung
- Trial name
- NCT03309358
- Testing
- Inhaled SNSP113
- Where
- 2 sites in United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Synspira, Inc.
Infection, Soft Tissue, Infection, Wound
Direct Antibiotic Delivery of Cefazolin Into Soft Tissue Infections Using Subcutaneous Injection and Ultrasonic Dispersion
This study focuses on a new drug delivery system (Direct Antibiotic Delivery) to treat soft tissue infections. In this study, cefazolin is delivered directly to the target tissues using subcutaneous injection of antibiotic…
- Conditions
- Infection, Soft Tissue, Infection, Wound, Cellulitis, Diabetic Foot Ulcer
- Trial name
- DAD (NCT01238276)
- Testing
- Cefazolin, Silberg Tissue Preparation System
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Sonescence, Inc.
Chronic Rhinosinusitis With Nasal Polyps
Study to Evaluate Safety and Activity of TRL1068 in Chronic Rhinosinusitis
TRL1068 is expected to eliminate the pathogen-protecting biofilm in Chronic Rhinosinusitis, thus making these bacteria substantially more susceptible to established antibiotic treatment regimens.
- Trial name
- NCT05355207
- Testing
- TRL1068
- Volunteers
- 12 people
- Sponsor
- Trellis Bioscience LLC
Drug Related Side Effects and Adverse Reactions, Infusion Reactions
Retrospective Kinetic Safety Evaluation of an Intravenous Micellar Excipient Platform
Protocol PICO-RWE-001: The goal of this observational study is to evaluate the kinetic safety and tolerability of an investigational intravenous micellar delivery platform.
- Trial name
- NCT07609069
- Testing
- PIV-850 (850-picometer Dual-NCE Acidic Matrix), Legacy Heterogeneous Payload (Micellar Vehicle)
- Where
- United States
- Volunteers
- 625 people
- Sponsor
- PICO IV, Inc.
Bacterial Infections
Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.
- Trial name
- NCT00423657
- Testing
- ceftaroline, vancomycin plus aztreonam
- Where
- 54 sites in United States, Argentina and 10 more
- Volunteers
- 680 people
- Sponsor
- Forest Laboratories
Antibiotic-associated Diarrhea
Prevention of Antibiotic-Associated Diarrhoea With Prolardii
Prolardii contains intestinal bacteria, a yeast, a fructo-oligosaccharide and a plant extract that can contribute to the intestinal comfort.
- Trial name
- PAADI (NCT03256708)
- Testing
- Prolardii
- Where
- Belgium
- Volunteers
- 220 people
- Sponsor
- Therabel Pharma SA/NV
UTI - Lower Urinary Tract Infection, Antibiotic Resistant Infection
Efficacy of Ciprofloxacin for the Treatment of Uncomplicated Urinary Tract Infection (uUTI)
This is a prospective, Phase 4, open label, multi-center study of the clinical and microbiologic efficacy of ciprofloxacin for the treatment of uncomplicated urinary tract infections in adult women.
- Trial name
- NCT03366207
- Testing
- Ciprofloxacin
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Iterum Therapeutics, International Limited
Vancomycin-Resistant Enterococcus, Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae, or Carbapenem-Resistant Enterobacteriaceae Colonized Subjects
VITORA: Clinical Study to Evaluate the Effect of KB109 on the Gut Microbiome in Subjects Whose Gastrointestinal Tracts Are Colonized With Multiple Drug-resistant Organisms
This randomized, open-label, clinical study aims to explore the safety and tolerability of KB109, a novel glycan, versus an observational control group on the gut microbiome in subjects whose gastrointestinal tracts are colonized…
- Trial name
- VITORA (NCT03944369)
- Testing
- KB109, No intervention
- Where
- 8 sites in United States
- Volunteers
- 3 people
- Sponsor
- Kaleido Biosciences
Pneumonia, Pneumococcal, Community Acquired Infections
New Antibiotic to Treat Patients With Community-acquired Pneumonia Due to a Specific Bacteria (S. Pneumoniae Pneumonia)
This study will treat patients who have a community-acquired pneumonia that is due to a specific bacteria (S. pneumoniae)
- Conditions
- Pneumonia, Pneumococcal, Community Acquired Infections, Gram-positive Bacterial Infections
- Trial name
- NCT00035269
- Testing
- Antibiotic
- Where
- 46 sites in United States, Slovakia and 2 more
- Volunteers
- 230 people
- Sponsor
- Pfizer
Escherichia Coli Infections, Klebsiella Infections
Study Evaluating Antibiotic Use in Reducing Vancomycin-Resistant Enterococci and ESBL Producing Escherichia Coli and Klebsiella Pneumoniae in Intensive Care
To determine whether the restriction of 3rd generation cephalosporins and carbapenems contribute to the reduction of intestinal colonization or infection with vancomycin-resistant enterococci (VRE) in a medical intensive care…
- Trial name
- NCT00167986
- Testing
- vancomycin-resistant enterococci and ESBL
- Where
- South Korea
- Volunteers
- 480 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Bacterial Infections
A Single Dose Study of Debio 1450 in Healthy Subjects
The sponsor is trying to develop a medicine for infections that are not cured by regular antibiotics. They have an experimental drug called Debio 1450 that may work. They need about 48 healthy adults to volunteer for this study.
- Trial name
- NCT02162199
- Testing
- Debio 1450
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Debiopharm International SA
Healthy Subjects
Safety, Tolerability, Pharmacokinetics and Food Effects Study of PBTZ169
Open-label prospective non-comparative ascending dose randomized cohort study of single and multiple oral administration of PBTZ169 (capsules 80 mg) in healthy volunteers
- Trial name
- NCT04150224
- Testing
- PBTZ169 640 mg OD, PBTZ169 640 mg BiD, PBTZ169 960 mg SD
- Where
- Russia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Nearmedic Plus LLC
Antibiotic Resistant Bacteria
Effect of Minocycline & Amoxicillin on Antibiotic Resistant Bacteria and Indigenous Microbiotas
A randomised, open labelled study design is selected in order to determine the emergence and persistence of antibiotic resistant bacteria in humans and on the composition of the indigenous microbiotas at various body sites.
- Trial name
- ANTIRESDEV (NCT02030912)
- Testing
- 3 doses of amoxicillin daily for 7 days, 2 doses of minocycline daily for five days
- Where
- United Kingdom
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Helperby Therapeutics Ltd
Infectious Disease, Bacterial Infections
Safety & Efficacy of an Antibacterial Protein Molecule Applied Topically to the Nostrils of Volunteers and Patients
The purpose of this study is to determine whether the antibacterial protein P128 is (i) safe and well tolerated in healthy volunteers and in chronic kidney diseases patients on dialysis, (ii) is it effective in reducing the nasal…
- Trial name
- NCT01746654
- Testing
- P128-0.1 mg, P128-0.3 mg, P128-1.0 mg
- Where
- Singapore
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- GangaGen, Inc.
Bacteremia Due to Staphylococcus Aureus, Left Sided Infective Endocarditis (Disorder)
ERAdicate S. Aureus in Patients With Bacteremia and Endocarditis
This study evaluates safety and tolerability of endolysin-derived LSVT-1701 (tonabacase) as an add-on to standard of care (SOC) antibiotic therapy for the treatment of patients with complicated Staphylococcus aureus bacteremia…
- Conditions
- Bacteremia Due to Staphylococcus Aureus, Left Sided Infective Endocarditis (Disorder), Right Sided Infective Endocarditis (Disorder), Endocarditis Infective
- Trial name
- ERASE (NCT05329168)
- Testing
- Tonabacase (LSVT-1701)
- Where
- United States
- Sponsor
- Lysovant
Bacterial Infections
A Multiple Dose Study of Debio 1450 [Intravenous (IV) and Oral] in Healthy Volunteers
Debio 1450-103 is a trial to study the pharmacokinetics (PK) of an experimental drug called Debio 1450 in healthy adult volunteers. Originally, Part A was registered separately (in NCT02214355).
- Trial name
- NCT02214433
- Testing
- Debio 1450 IV Solution, Debio 1450 Tablet, Debio 1450 Capsule
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Debiopharm International SA